Regulatory Research Perspectives Online Journal

April 2009, Volume 8, Issue 1: "FDA Bioinformatics Tool for Public Use-ArrayTrack™"

The formation of the Human Genome Project in 1990 to complete the entire DNA sequence of ourselves initiated an era of unprecedented growth in knowledge of human biology and opened the door to the future of medicine that we see unfolding today. The general scientific discipline descending from the genome project is commonly called “genomics,” followed by the science for analysis of protein patterns resulting from the gene product (or “proteomics”) and then the measurement of the flux of these proteins during metabolism (“metabolomics or metabonomics”) have developed. Through these high-throughput technologies, science is prepared to define the threads between the observations of scientific investigations and the observations of nearly 2500 years of medicine that began with the great Greek physician, Hippocrates (ca. 460-367 BC).

Ethical, legal, and social issues attendant to the genome project are often a leading manifestation of this accomplishment to the general public along with terms such as “gene therapy” and “personalized medicine” coming into everyday usage. Parallel to known public accomplishments and arising ethical issues leading from the genome project came nearly silent but equally astounding leaps in technological innovation supporting these sciences, and an ever burgeoning level of information produced from these technologies, nearly unimaginable only a few years before, had to be stored and analyzed. From this basic need, and the need for the Food and Drug Administration to evaluate the results and impact of these technologies upon the health and safety of drugs, biologics, foods and medical in a predicable and efficient manner, came the development of ArrayTrack™. ArrayTrack™ is a publically available tool that provides a uniform storage facility for the vast amounts of genomic, proteomic, and metabolomics data accumulated in clinical and preclinical studies; a library assembly for all related data in public repositories, chemical characterization, and data analysis tools for establishing relationships and predictions to the repository of human physiologic knowledge. Outgrowths of this project have also included enterprises to establish uniform standards for the accumulation, storage, and possible interpretations of data arising during the post-genome era.

The objective of the Regulatory Research Perspectives journal is to provide a vehicle for FDA scientists to communicate important scientific information to each other with the hope of generating collaborations and to communicate to the global community science that is important to the Agency. It is hoped that each center will submit manuscripts for publication through their respective editorial board members. See the "Instructions to Authors" provided on this site.

Some of these documents are in Portable Document Format to retain the original format. To view or print these documents, you must use the Adobe Acrobat viewer. Acrobat is free and available directly from Adobe's web site with full installation instructions.


abrir aquí para acceder al documento general y desde allí a sus secciones:
Regulatory Research Perspectives Online Journal